On-the-fly form generation and on-line metadata configuration--a clinical data management Web infrastructure in Java.

In this paper we describe the approach to build a web-based clinical data management infrastructure on top of an entity-attribute-value (EAV) database which provides for flexible definition and extension of clinical data sets as well as efficient data handling and high performance query execution. A "mixed" EAV implementation provides a flexible and configurable data repository and at the same time utilizes the performance advantages of conventional database tables for rarely changing data structures. A dynamically configurable data dictionary contains further information for data validation. The online user interface can also be assembled dynamically. A data transfer object which encapsulates data together with all required metadata is populated by the backend and directly used to dynamically render frontend forms and handle incoming data. The "mixed" EAV model enables flexible definition and modification of clinical data sets while reducing performance drawbacks of pure EAV implementations to a minimum. The system currently is in use in an electronic patient record with focus on flexibility and a quality management application (www.healthgate.at) with high performance requirements.